Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER)

Centre Hospitalier Departemental Vendee

Status: Completed

Conditions: Ventilator-associated Pneumonia

Treatments: Device: Endotracheal tubes allowing SSD; Device: Endotracheal tubes not allowing SSD

Study type: Interventional

Funder types: Other

Identifiers

NCT02515617

CHD 045-14

Details and patient eligibility

About

In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.

Enrollment: 2,577 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age over 18 years
• Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
• Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
• Information delivered

Exclusion criteria

• Previous inclusion in the study
• Patients moribund at the ICU admission
• Pregnant, parturient or breast-feeding woman
• Patient hospitalized without consent and/or deprived of liberty by court's decision
• Patient under guardianship or curators
• Lack of social insurance
• Concomitant inclusion in a trial on VAP prevention
• Patient with no comprehension of the French language

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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2,577 participants in 2 patient groups

Period with endotracheal tubes not allowing SSD

Active Comparator group

Description:

During this period, patients will be intubated with standard endotracheal tubes not allowing Subglottic Secretions Drainage

Treatment:

Device: Endotracheal tubes not allowing SSD

Period with endotracheal tubes allowing SSD

Experimental group

Description:

During this period, patients will be intubated with specific endotracheal tubes allowing Subglottic Secretions Drainage

Treatment:

Device: Endotracheal tubes allowing SSD